FDA May Remove Age Restrictions From Morning-After Pill Plan B

The Food and Drug Administration (FDA) may move to eliminate age restrictions for the morning-after emergency contraception pill, Plan B One-Step, according to several people involved with the deliberations who spoke with TIME Healthland.

The morning-after pill is currently available without a prescription to users aged 17 or older. Younger teens still require a prescription. If the FDA does away with that restriction, it could bring the emergency contraception pill from behind the pharmacist’s counter to store shelves, alongside more familiar over-the-counter medications like antacids and painkillers.

In February, Plan B’s manufacturer, Teva Pharmaceuticals, filed an application with the FDA to move the pill from “dual label” status, which requires it to be sold under hybrid over-the-counter and prescription-drug regulations, to full over-the-counter status, which would remove the age restriction. As part of agency policy, an FDA spokesperson declined to comment on the case, but people close to the process expect the agency to meet the deadline for announcing its decision on Wednesday, Dec. 7.

Such a change in labeling has been long anticipated by public health experts and many legislators, who have urged the FDA to widen women’s access to emergency contraception since at least 2003, when Plan B’s manufacturer first asked the agency to make it available over the counter to consumers of any age. That decision was three years in the offing, mired in a national debate over reproductive rights. Abortion-rights groups said increased access to emergency contraception would lower the rate of abortion in the U.S., while anti-abortion groups predicted the opposite, warning that it would lead to more abortion and encourage riskier teen sex.

Despite an FDA advisory council’s recommendation in 2003 to allow prescription-free sales of the drug, the FDA repeatedly delayed its decision, in large part to appease the conservative anti-abortion faction, many critics said. In 2006, the FDA finally made the morning-after pill available without a prescription to women aged 18 or older. In 2009, the age cutoff was lowered to 17.

“This label change is long overdue,” says Amy Allina, director of programming for the National Women’s Health Network. “It’s not just a victory for women’s health. It’s a victory for science at the FDA. There was never any medical justification for having an age restriction for the product.”

Plan B One-Step contains a high dose of the progestin hormone levonorgestrel, the same hormone as in birth control pills. When taken within 72 hours of unprotected sex, it can prevent pregnancy. But it is most effective within 24 hours of sex and so any barrier to getting the drug — such as waiting for a doctor’s prescription or having to face a pharmacist — reduces the chances that it will be taken in time, or at all.

Making access easier is likely to increase use: in the two-year period after the FDA approved emergency contraception for over-the-counter sales, the rate of use more than doubled, compared with the four-to-six year period before that when it was available by prescription only, according to data reported by the Guttmacher Institute in April. Tellingly, the percentage of women who had discussed emergency contraception with a doctor did not change between the two periods, but the overall rate of use remained low, the study found.

As for the question of whether emergency contraception leads to more unsafe sex, at least one study of 15-to-20-year-old women who were provided with emergency contraception shows that preemptive access didn’t reduce pill or condom use — or increase the likelihood of unprotected sex. Abortion and teen birth rates are down as well, although it’s impossible to know how much of this can be attributed to the use of emergency contraception; given how few women use it, the impact is unlikely to be significant.

Overall, the data suggest that making Plan B as easy to get as aspirin will serve to benefit women’s health, without increasing harm. Keeping Plan B “behind the counter and having to go through a gatekeeper — it replaces the prescription barrier with another one,” says Dr. Daniel Grossman, a senior researcher at Ibis Reproductive Health and an Assistant Clinical Professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco. “We know it’s a very, very safe drug that’s impossible to overuse or abuse. Really, it should be on the shelf.”

Indeed, one could argue that it’s safer than aspirin: overdoses of over-the-counter painkillers like aspirin and ibuprofen can lead to serious liver, kidney or gastrointestinal problems, or even death. In contrast, it is impossible to overdose on Plan B. The drug is not used in the manufacture of illegal substances nor is it possible to abuse it like cough medicine. And although combination birth control pills containing both estrogen and progesterone are associated with a very slight elevation in stroke and blood clot risk, the progestin-only emergency contraception is not.

According to Teva, two new studies of younger users support the eliminating of the age restriction. One study involving 335 girls aged 12 to 17 showed that 72% to 96% of them understood the proposed package label well enough to use emergency contraception safely and effectively without consulting a doctor. Another study, involving about 300 girls aged 11 to 16, came to a similar conclusion.

Plan B One-Step is not the only emergency contraceptive currently on the market. The others are a generic form of Plan B, called Next Choice, which is also available over the counter for anyone 17 or older, and Ella, a more effective prescription-only emergency contraceptive that may be taken within five days of unprotected sex. But Plan B One-Step is the only drug being considered for a label change; even the drug’s generic form, which comes in a two-pill dose, will not qualify for full over-the-counter status.

That’s another hurdle to the drug: Plan B is expensive. But researchers like Grossman are hoping that the cost will not hinder women — at least not those with health insurance — since emergency contraception will be covered by insurance as preventive care. Health and Human Services guidelines require insurance plans to cover the full cost of women’s preventive care — including FDA-approved birth control pills and emergency contraceptives — as part of the health reform law passed in 2010.

Mostly, public health experts hope that a label change will help spread the word to more women that Plan B is available and safe. “It helps draw home the assertion that we’ve made all along — that it’s safe for everyone to use,” says Allina. “There’s an implication if it’s not as available that there’s something different about it.”

Meredith Melnick is a reporter at TIME. Find her on Twitter at @MeredithCM. You can also continue the discussion on TIME’sFacebook page and on Twitter at @TIME.